An Eight-Week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT00358631|
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : April 13, 2009
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder||Drug: SSR149415||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||319 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||An Eight-Week, Multicenter, Double-Blind, Placebo- and Escitalopram-Controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Major Depressive Disorder|
|Study Start Date :||July 2006|
|Primary Completion Date :||December 2007|
|Study Completion Date :||December 2007|
- The primary efficacy endpoint is the change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
- The main secondary endpoints are the changes from baseline to Day 56 in the HAM-D depressed mood item, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Clinical Global Impression (CGI) Severity of Illness scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358631
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||ICD CSD||Sanofi|